NORTH
CHICAGO, Ill. & NEW YORK—AbbVie and Bristol-Myers Squibb Co. (BMS) are entering into a collaboration with the goal of exploring the safety and potential enhanced efficacy of combining
checkpoint inhibitors with a cancer stem cell-targeting antibody-drug conjugate in small cell lung cancer (SCLC). To that end, they announced July 25 a
clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational biomarker-specific antibody-drug conjugate
Rova-T (rovalpituuzumab tesirine) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment
for relapsed extensive-stage SCLC.

The Phase 1/2 clinical program will explore the potential of combining the BMS immuno-
oncology agents, which are designed to alleviate immune suppression, in conjunction with AbbVie’s investigational antibody-drug conjugate, Rova-T, to
drive improved and sustained efficacy and tolerability above the current standard of care. Rova-T is a novel antibody-drug conjugate that targets and
eliminates tumor initiating cells and other bulk tumor cells. This collaboration will determine if the targeted cell killing and antigen release caused by
Rova-T may further enhance the effect of immunotherapy.

“We are excited to explore the potential benefits of
combining Bristol-Myers Squibb’s immunotherapies with a targeted approach like Rova-T in small cell lung cancer, where the need for new therapies is
particularly acute for this aggressive form of lung cancer,” said Dr. Jean Viallet, global clinical research lead for oncology at BMS. “As the
science around cancer research continues to rapidly evolve, we are building on our leadership in immuno-oncology with numerous collaborations that may help
advance new therapies for cancers in need of better options.”

“We believe the combination of these
cancer-fighting agents may offer patients a new treatment option in a disease with limited therapies,” said Dr. Scott J. Dylla, vice president of
research and development at AbbVie. “By combining immune-checkpoint inhibitors that prime the body’s immune system to fight cancer cells with
Rova-T’s approach to target cancer stem cells, we hope to build on our goal to develop differentiated treatments with therapeutic benefit that elevate
the standard of care for small cell lung cancer patients.”

Rova-T is a novel biomarker-specific therapy that
targets cancer stem cells and combines a targeted antibody that delivers a cytotoxic agent directly to cancer cells expressing a delta-like protein 3 (DLL3).
DLL3 is expressed in more than 80 percent of SCLC patient tumors and is not present in healthy tissue. Rova-T is currently in investigational studies as a
third-line treatment for SCLC. AbbVie will initiate a first-line clinical study for Rova-T in SCLC and several other types of tumors in the near term.

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July
2014, and currently has regulatory approval in 54 countries including the United States, Japan, and in the European Union. Yervoy is a CTLA-4 immune
checkpoint inhibitor approved in 50 countries globally for patients with unresectable or metastatic melanoma.

As
we reported in the July issue of DDNews, recent data from the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting indicated that Rova-T
used to treat recurrent/refractory SCLC represented a promising new approach as the first biomarker-directed therapy for treating the disease.

Rova-T appears safe and shows efficacy in treating patients with advanced SCLC, according to results from a first-in-human
clinical trial presented by a Memorial Sloan Kettering Cancer Center (MSKCC) researcher at the ASCO
meeting. The findings also show that patients responded better to the drug when their tumors expressed high levels of DLL3.

AbbVie reported that treatment with Rova-T demonstrated a confirmed overall response rate of 39 percent and clinical benefit rate (stable disease
or better) of 89 percent in patients with recurrent or refractory SCLC identified with high expression of DLL3. Rova-T demonstrated a one-year overall
survival rate of 32 percent in the recurrent/refractory second- and third-line patient population.

“The goal
is always to give the right patient the right drug at the right time, but patients with advanced small cell lung cancer have not benefited from any of the
new targeted therapies available to patients with other types of cancer,” commented Dr. Charles M. Rudin, chief of the Thoracic Oncology Service at
MSKCC, who presented the findings at the ASCO meeting. “They desperately need new treatment options, so the ability to predict whether a patient might
respond to Rova-T by testing their tumor for overexpression of the DLL3 protein is crucial, because it may ultimately help us give this drug to the patients
most likely to benefit from it and avoid giving it to patients who won’t.”

Rudin added, “These
data further contribute to our understanding of the potential impact that treatment with Rova-T, a predictive biomarker-based therapy, could have on
pretreated small cell lung cancer patients identified as high expressers of DLL3. The results presented at ASCO support further clinical development of this
compound.”